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Carpel Tunnel Syndrome and Physical Therapy Modalities

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

pulsed electromagnetic field

Therapeutic ultrasound

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring median nerve, wrist joint, carpal tunnel

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Mild to moderate CTS
Positive electro diagnostic findings: prolonged median motor distal latency (MMDL) above 4 ms, and below 6ms.
Prolonged median sensory distal latency above 3.5 ms .
Positive Phalen and Tinel test.
Subjects scored pain intensity more than 5 in visual analogue scale (VAS).

Exclusion Criteria:

severe cases with delayed motor distal latency > 6ms.
Orthopedic or neurological disorders of neck or the upper limb as cervical radiculopathy.
Pronator teres syndrome or double crush syndrome.
Pre- existing CTS before their last pregnancy, current pregnancy.
Diabetic neuropathy and Thoracic outlet syndrome.
Wasting of thenar muscles, ulnar neuropathy.
Rheumatoid arthritis, previous fractured carpal bone and previous surgery in the forearm especially transverse ligament release

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

pulsed electromagnetic field (PEMF)

Therapeutic ultrasound (US)

Arm Description

patients in this group received the pulse electromagnetic field with frequency 50 Hz and intensity 80 gauss for 30 min.The patient was in sitting position, while the forearm was rested on the bed inside the solenoid in supination position

Pulsed mode US was applied over the volar surface of the forearm (the carpal tunnel area) 15 min per session with a frequency of 1 MHz and intensity of 1.0 W/cm2

Outcomes

Primary Outcome Measures

Pain intensity

it measured by the Visual Analogue Scale (VAS).It is considered a valid way of assessing pain

Secondary Outcome Measures

Functional status scale

It is a part of the Carpal Tunnel Syndrome Questionnaire (CTSQ). it asks about eight functional activities as writing, buttoning of clothes, gripping of a telephone handle

Full Information

NCT ID

NCT02745652

First Posted

April 14, 2016

Last Updated

April 20, 2016

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02745652

Brief Title

Carpel Tunnel Syndrome and Physical Therapy Modalities

Official Title

Pulsed Magnetic Field Versus Ultrasound in Treatment of Postnatal Carpal Tunnel Syndrome: Randomized Control Trial on Female Egyptian Population

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to continue postnatal. Conservative treatment is more recommended in these cases. There are many physical therapy modalities proposed to treat CTS without knowing which modality is better than the other. So the aim of this study to compare the effect of two modalities in treating CTS in postnatal females.

Detailed Description

Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment disorders in the upper limb. CTS is common during pregnancy especially in the third trimester as well, a significant percentage of females postnatal may still have some complaints up to at least 3 years postnatal. Purpose: To compare the effect of pulsed magnetic field (PEMF) versus ultrasound (US) in treating patients with CTS. Forty postnatal female patients with idiopathic CTS were assigned randomly into two equal groups. One group received PEMF with nerve and tendon gliding exercises for the wrist 3 times for week for 4 weeks. The other group received US plus the same exercises. Pain level, sensory and motor distal latencies of the median nerve (MSDL and MMDL), sensory and motor conduction velocities of the median nerve (MSCV and MMCV), functional status scale and hand grip strength were assessed pre and post treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

Keywords

median nerve, wrist joint, carpal tunnel

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pulsed electromagnetic field (PEMF)

Arm Type

Experimental

Arm Description

Arm Title

Therapeutic ultrasound (US)

Arm Type

Experimental

Arm Description

Pulsed mode US was applied over the volar surface of the forearm (the carpal tunnel area) 15 min per session with a frequency of 1 MHz and intensity of 1.0 W/cm2

Intervention Type

Device

Intervention Name(s)

pulsed electromagnetic field

Other Intervention Name(s)

(PEMF)

Intervention Description

it is a magnetic device for magneto-therapy, it has an appliance, motorized bed, and applicable large solenoids which can be moved in 4 different positions according to the treatment area, and the additional small solenoid for hand treatment with 30 cm diameter

Intervention Type

Device

Intervention Name(s)

Therapeutic ultrasound

Other Intervention Name(s)

Intervention Description

Ultrasound is applied using a transducer or applicator that is in direct contact with the patient's skin. Gel is a medium which is used on all surfaces of the head to reduce friction and assist transmission of the ultrasonic waves

Primary Outcome Measure Information:

Title

Pain intensity

Description

it measured by the Visual Analogue Scale (VAS).It is considered a valid way of assessing pain

Time Frame

4 weeks change from the baseline scores

Secondary Outcome Measure Information:

Title

Functional status scale

Description

It is a part of the Carpal Tunnel Syndrome Questionnaire (CTSQ). it asks about eight functional activities as writing, buttoning of clothes, gripping of a telephone handle

Time Frame

4 weeks change from the baseline scores

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mild to moderate CTS Positive electro diagnostic findings: prolonged median motor distal latency (MMDL) above 4 ms, and below 6ms. Prolonged median sensory distal latency above 3.5 ms . Positive Phalen and Tinel test. Subjects scored pain intensity more than 5 in visual analogue scale (VAS). Exclusion Criteria: severe cases with delayed motor distal latency > 6ms. Orthopedic or neurological disorders of neck or the upper limb as cervical radiculopathy. Pronator teres syndrome or double crush syndrome. Pre- existing CTS before their last pregnancy, current pregnancy. Diabetic neuropathy and Thoracic outlet syndrome. Wasting of thenar muscles, ulnar neuropathy. Rheumatoid arthritis, previous fractured carpal bone and previous surgery in the forearm especially transverse ligament release

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

publication in a refereed journal

Learn more about this trial

Carpel Tunnel Syndrome and Physical Therapy Modalities

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